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1 May 7, 2012 Ms. Marilyn Tavenner Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-0044-P Mail Stop C Security Boulevard Baltimore, MD Re: Medicare and Medicaid Programs Electronic Health Record Incentive Program Stage 2 Dear Acting Administrator Tavenner: Thank you for the opportunity to comment on the Electronic Health Record (EHR) Incentive Program Stage 2 proposed rule. The American Osteopathic Association (AOA) which represents more than 78,000 osteopathic physicians nationwide supports the adoption of health information technology (HIT). The AOA supports efforts to ensure that all patient populations, especially those in rural and underserved communities, benefit from HIT. Promoting wellness and improving the overall quality of care that patients receive are the cornerstones of osteopathic medicine. Our goal is to support best practice: practice evidence-based medicine, focus on quality improvement activities, and use information technology appropriately. The AOA also recognizes that making the decision to go forward with an EHR system requires a considerable amount of time and financial investment for a physician s practice. The adoption, implementation, and upgrading of an EHR system is a major and costly undertaking. Success depends on a multitude of factors, including decisions on system evaluation, selection, contracting, configuration, implementation, training, management, and oversight. The AOA commends CMS for the proposed modification to the program timeline to provide a one year extension to Stage 1 for providers who first attested to Stage 1 criteria for Medicare in However, we are concerned that even with the timeline modification it will still be difficult for many physicians to meet many of the objectives as proposed for Stage 2. We note that as proposed the thresholds for many Stage 2 objectives are substantially raised. We understand that the regional extension centers (RECs) are available to assist physicians in meeting this program s requirements. However, we remain concerned that some physician practices, particularly smaller practices that are undergoing a complete practice transformation - from step 1, i.e. a complete transition from a paper-based to an electronic based practice, will still find it difficult

2 Page 2 to meet these increased thresholds. A study in the May 2012 edition of Health Affairs states there is a continuing lag in electronic health records systems adoption in several areas. One of the areas of note referenced in this study is the lag in EHR adoption for physicians in small (1 to 2 providers) and physician-owned practices. There appears to be no scientific basis for many of the thresholds specified. The percentage increase from Stage 1 to Stage 2 for many objectives is significant. High thresholds should be avoided for new measures. High thresholds also should be avoided for measures that cannot be met due to the lack of available well-tested tools or bidirectional health information exchanges. In setting proper thresholds for Stage 2 and future stages of meaningful use, CMS must factor in lessons learned to date and research to ensure thresholds for meaningful use are evidence-based. Measures that require participation from another party other than the physician (for example a patient accessing their health information through a portal) and that are beyond a physician s control should be removed or modified. Overall, CMS needs to provide more flexibility with its measures. We also note that as proposed beginning in 2015, there will be downward payment adjustments for eligible professionals and hospitals that are not meaningful users of Certified EHR Technology. We understand that CMS proposes to base the 2015 penalty on 2013 or 2014 meaningful use data. We urge CMS to reconsider use of 2013 and 2014 data for determination of the 2015 payment adjustment. We believe CMS should use data from 2015 in determining any payment adjustments for that year. In addition, it is our understanding there has been no comprehensive Stage 1 feedback received to date from eligible professionals participating in the EHR Incentive Program. To ensure that physicians can successfully participate and meet the program s objectives in future stages, it is critical that feedback be received and evaluated on experiences from Stage 1. CMS and ONC should survey physicians to include those who did participate and also those that did not participate in Stage 1 and identify barriers and solutions for physician participation prior to finalizing the requirements for Stage 2. Finalized requirements must take into consideration specific challenges physician practices face in adopting and implementing electronic health records and the impact those challenges will have on patient care. They include: Costs- It continues to be difficult for many physicians, particularly those in smaller practices, to make the significant upfront financial investment required to purchase and implement an EHR system. A majority of osteopathic physicians have small practices specializing in primary care areas of family medicine, internal medicine, obstetrics and gynecology, and pediatrics. While we appreciate the financial incentives offered under this program, the lack of upfront capital for physicians to purchase an EHR system is a continuing barrier to HIT adoption. This factor is cited in the 2012 study by Deloitte Center for Health Solutions entitled Physician Perspectives on Health Information Technology. In this study, 66% of those surveyed cited the upfront financial investment required as their primary concern. It is also important to note that physicians face significant economic instability with major reductions to reimbursements pending if there is no resolution to the Sustainable Growth Rate formula.

3 Page 3 Physicians face other increasing costs as well. For example, as of April 16, the Drug Enforcement Administration (DEA) significantly increased its registration fee for practitioners and dispensers by more than 32% to $731 for a three-year registration period. HIT Interoperability - There is great concern that when a significant investment is made in an HIT system that the purchased system will not be able communicate or exchange health information with other entities. We understand that Stage 2 and future stages of meaningful use include increasing requirements for health information exchange. The success in EHR adoption and implementation hinges on a sound infrastructure and interoperability that involves many players outside of the physician s practice. In a February 2012 survey conducted by the National ehealth Collaborative, stakeholders were asked What are the biggest challenges to achieving widespread health information exchange? The top responses were: 61% - funding and sustainability, 53% interoperability standards, 46% for provider adoption, and 46% for disparate electronic medical record systems. The interoperability issue must be addressed in order for the seamless exchange of health information to occur and support coordination of care across providers, settings, and systems. Interoperability remains a major challenge and barrier to implementing EHR systems. Achieving interoperability is not the responsibility of the physician. Other program requirements - Although the EHR Incentive Program is voluntary, it is one of several programs that have requirements physicians are expected to meet. These requirements must be in alignment with other existing programs. For example, we understand that beginning in 2014, CMS proposes to align clinical quality measures in this program with other quality initiatives such as the Physician Quality Reporting System (PQRS). We are supportive of this effort as this will lessen the burden on physician practices. In addition, physicians also face several mandated requirements, such as ICD-10 coding. We commend CMS for delaying the ICD-10 compliance date to October 1, Proposed Stage 2 Objectives and Measures Core Measures EP Objective: Use CPOE for medication, laboratory, and radiology orders by any licensed health care professional who can enter orders into medical records. EP Core Measure: More than 60 percent of medication, laboratory, and radiology orders created by the EP during the EHR reporting period are recorded using CPOE. Recommendation: We believe the threshold for the CPOE measure should be 30 percent. Numerous challenges still exist regarding the use of CPOE. For example, many physicians do not use CPOE due to the lack of bidirectional health information exchanges. CMS should allow physicians to use CPOE for any combination of medication, laboratory, and radiology orders so long as the 30 percent threshold is met. In addition, we do not believe that CPOE should be expanded to include non-licensed health care professionals such as scribes. EP Objective: Generate and transmit permissible prescriptions electronically EP Core Measure: More than 65% of all permissible prescriptions written by the EP are compared to at least one drug formulary and transmitted electronically using Certified EHR Technology.

4 Page 4 Recommendation: We recommend that the percentage be decreased from 65 to 50 percent for this measure. This percentage is consistent with the recommendation put forth by the HIT Policy Committee of increasing the threshold for this percentage from 40 percent to 50 percent. We are concerned that the proposed percentage of 65 percent is too high and it will be difficult for many practices to achieve this objective, particularly those in rural areas. CMS acknowledges this factor in the proposed rule and notes that the ability of the EP to meet this measure depends on the EP having access to the availability of pharmacies in their area that accept electronic prescriptions. We remain concerned about the lack of interoperability between small local pharmacies and physician offices. Many pharmacies are simply not equipped to accept electronic prescriptions. According to the proposal, exclusions include any EP who writes fewer than 100 prescriptions during the EHR reporting period or does not have a pharmacy within their organization and there are no pharmacies that accept electronic prescriptions within 25 miles of the EP s practice location at the start of his/her EHR reporting period. The AOA supports these exclusions. However, we anticipate that many practices still will have difficulty meeting this objective. CMS should broaden the exclusion to include other barriers which prevent physicians from meeting the measure s requirements. For example, given the existing challenges surrounding prescriptions for controlled substances, physicians who have more patients that require those prescriptions should not be penalized if they are unable to prescribe those drugs electronically. EP Objective: Record demographics EP Core Measure: More than 80% of all unique patients seen have demographics recorded as structured data. Recommendation: We believe the proposed threshold is too high. It is our understanding that demographics are recorded through practice management systems. Many physician practices are in the process of integrating their practice management and electronic health record systems but this integration takes time. CMS should provide enough flexibility so that physicians are not duplicating their work. Physicians should be allowed to record what they think is pertinent to their patients care. EP Objective: Record and chart changes in vital signs EP Core Measure: More than 80% of all unique patients seen by EP record blood pressure (patients age 3 and over only) and height/length and weight (for all ages) recorded as structured data. Recommendation: We believe this objective is more appropriate as a clinical quality measure. EP Objective: Record smoking status for patients age 13 and older. EP Core Measure: More than 80% of all unique patients 13 years or older seen by the EP have smoking status recorded. Recommendation: We believe this objective is more appropriate as a clinical quality measure.

5 Page 5 EP Objective: Use clinical decision support to improve performance on high-priority health conditions EP Core Measures: Implement five clinical decision support interventions related to five or more clinical quality measures at a relevant point in patient care for the entire EHR reporting period and EP has enabled and implemented the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period. Both measures must be satisfied in order to meet this objective. Recommendation: We believe the threshold of five clinical decision support interventions is too high and too costly. In our Stage 1 letter, we recommended one CDS and for that to be delayed to Stage 2. While we believe one CDS is a sufficient threshold, physicians should not have to attest to implementing more than two CDS interventions. In addition, we believe more clarification is necessary regarding what is considered a high priority health condition and relevant point of care. CMS proposes that CDS intervention must be related to five or more of the clinical quality measures. Although CMS gives an example, it will be difficult for many physicians to make the determination, because depending on the physician s specialty and patient population, five CDS interventions may not be required. We do support implementing the drug-drug and drug-allergy interaction checks; however, physicians should have the flexibility to set their own thresholds. EP Objective: Incorporate clinical lab test results as structured data EP Core Measure: More than 55% of all clinical lab results ordered by the EP during the EHR reporting period whose results are either in a positive/negative or numerical format are incorporated in Certified E HR Technology structured data. Recommendation: The agency s proposal is problematic because many labs do not have interfaces with EHR systems, particularly involving physician practices. CMS should not make this a core requirement for Stage 2. We also believe the proposed 55 percent threshold should remain at 40 percent. It is our understanding that the physicians that are currently performing this function are the early adopters. The threshold needs to remain as is in order to allow EPs, currently in the process of implementing systems, the time to perform this function successfully. EP Objective: Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, or outreach. EP Core Measure: Generate at least one report listing patients with a specific condition. Recommendation: The AOA supports this objective. The AOA believes this function is important to the success of the patient-centered medical home. EP Objective: Use clinically relevant information to identify patients who should receive reminders for preventive/follow up care. EP Core Measure: More than 10% of all unique patients who have had an office visit with the EP within the 24 months prior to the beginning of the EHR reporting period were sent a reminder per patient preference.

6 Page 6 Recommendation: The AOA believes this function is important to the success of the patientcentered medical home. The measure should be flexible enough to allow for a variety of ways for sending out reminders that work most effectively for the practice and the patient. EP Objective: Provide patients the ability to view online, download, and transmit their health information within 4 business days of information being available to the EP. EP Core Measures: More than 50% of all unique patients seen by the EP during the EHR reporting period provided timely online access to their health information subject to the EP s discretion to withhold certain information and more than 10% of all unique patients seen by the EP (or their authorized representatives) view, download, or transmit to a third party their health information. The specified timeframe for providing this information to the patient is unrealistic and unreasonable. Physicians must have sufficient time to review patient information before releasing it to the patient. Under HIPAA, patients have a right to access, inspect, and obtain a copy of their protected health information. HIPAA gives physicians the flexibility to act on the request within 30 days. The proposed rule also states the patient must be able to access this information through a patient portal, personal health record (PHR), or other means. It is important to note that a patient portal is an advanced feature of an EHR system and requires significant investment of time, capital, and personnel to install and maintain which is difficult for small practices. It is our understanding that many portals which exist today are part of huge integrated systems, and are not common in smaller practices. In addition, we are extremely concerned with the component that the patient view, download, or transmit to a third party. EPs should not be held accountable for a measure that the patient will be required to perform. CMS seemingly agrees with this, noting in the proposed rule that it is a departure from most meaningful use measures, which are dependent solely on the actions taken by the EP. Recommendation: The timeline for patient requests to their health information should be consistent with HIPAA standards. This should not be a core requirement and should remain in the menu set. In addition, the threshold should be 20 percent. The second component should be eliminated altogether. EP performance should not be based on a factor that is beyond the eligible professional s control. EP Objective: Provide clinical summaries for patients for each office visit. EP Core Measure: Clinical summaries provided to patients within 24 hours for more than 50 percent of office visits. Recommendation: We believe the proposed measure is unrealistic and inconsistent with HIPAA standards. Physicians should have at minimum three business days to provide clinical summaries to their patients. Physicians need time to complete and review clinical summaries before releasing it to the patient. In addition, these summaries should only contain information that the physician and patient consider relevant and necessary. Physicians should be allowed to charge their patients a fee

7 Page 7 for clinical summaries which is permissible under the HIPAA rule. We also believe the 50 percent threshold is too high and overly burdensome. This threshold should be 20 percent. EP Objective: EP who receives a patient from another provider or setting of care or believes an encounter is relevant should perform medication reconciliation. EP Core Measure: EP performs medication reconciliation for more than 65% of transitions of care in which the patient is transitioned into the care of the EP. Recommendation: The AOA appreciates the importance of medication reconciliation. As noted by CMS, medication reconciliation allows providers to confirm that the information they have on the patient s medication is accurate. This not only assists the provider in their direct patient care, it also improves the accuracy of information they provide to others through health information exchange. In our previous comments, we raised concerns about the threshold and the burden related to the measure that requires manual calculation. Those concerns remain. However, we support the agency s position that the measure of this objective does not dictate what information must be included in medication reconciliation. Information included in the process of medication reconciliation is appropriately determined by the provider and patient. We also agree that while the objective is to conduct medication reconciliation at all relevant encounters, determining which encounters are relevant beyond transitions of care is too subjective to be included in the measure. EP Objective: EP who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care provides a summary of care record for each transition of care or referral. EP Core Measure: Both measures must be satisfied in order to meet the objective. EP that transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 65% of transitions of care and referrals. EP that transitions or refers their patient to another setting of care or provider of care electronically transmits a summary of care record using Certified EHR Technology to a recipient with no organizational affiliation and using a different Certified EHR Technology vendor than the sender for more than 10 percent of transitions of care and referrals. Recommendation: The AOA supports the providing a summary of care for transitions and referrals of care as a way of providing better continuity of care for patients. However, we believe the proposed threshold is too high and should be 50 percent. We also believe the measure should remain in the menu set. We are greatly concerned with the second objective measure that would require 10 percent of transitions of care be sent electronically to a different provider outside of the organization and to a different vendor. This measure is totally impractical and should be eliminated. Such a requirement adds to the administrative burdens physicians already have in complying with Medicare regulations. Physicians should not have to determine what EHR systems other providers are using. We understand in some geographic regions there is often a single vendor that dominates the market in that region. Physicians do not have control over the vendors that currently exist in the marketplace in their area.

8 Page 8 EP Objective: Capability to submit electronic data to immunization registries or immunization information systems except where prohibited. EP Core Measure: Successful ongoing submission of electronic immunization data from Certified EHR Technology to an immunization registry or immunization information system for the entire EHR reporting period. Recommendation: AOA does not believe this should be a core measure. Electronic interactions with immunization registries and public health agencies remain a challenge. We believe such interfacing requires testing and must demonstrate mature functionality; otherwise physicians will be faced with another burden of having to determine the capabilities of electronic systems outside of their control. EP Objective: Protect electronic health information created or maintained by Certified E HR Technology through the implementation of appropriate technical capabilities. EP Core Measure: Conduct or review a security risk analysis including addressing the encryption/security of data at rest and implement security updates as necessary and correct identified security deficiencies as part of the EP s risk management process. Recommendation: The AOA supports this measure. The AOA suggests that CMS provide additional guidelines and tools that would assist physician practices successfully achieve this objective. EP Objective: Use secure electronic messaging to communicate with patients on relevant health information. EP Core Measure: A secure message was sent using the electronic messaging function of Certified EHR Technology by more than 10 percent of unique patients seen by the EP during the EHR reporting period. Recommendation: We are extremely concerned with this core measure. We do not agree this objective s measure is applicable to eligible professionals. EPs should not be held accountable for a measure that the patient will be required to perform. To reiterate again, CMS notes in the proposed rule that it is a departure from most meaningful use measures, which are dependent solely on the actions taken by the EP. We believe this proposal as it is currently written should be removed from the final rule. It should not be a core objective. EP performance should not be based on a factor that is beyond the eligible professional s control. If CMS decides not to remove this proposal, it should at minimum revise this measure so that the messaging is from the physician, not the patient, and the measure should go into the menu set. Menu Measures EP Objective: Capability to submit electronic syndromic surveillance data to public health agencies except where prohibited. EP Menu Measure: Successful ongoing submission of electronic syndromic surveillance data from Certified EHR Technology to a public health agency for the entire EHR reporting period.

9 Page 9 Recommendation: CMS notes in the proposed rule that very few public health agencies are currently accepting syndromic surveillance data from providers. We understand this is not a core set requirement for EPs, but is in the menu set. We recommend that this objective remain in the menu set until public health agencies have the capability to accept this data from providers. However, ongoing submissions of electronic syndromic surveillance data should not be required. Again, physicians should not be placed in a situation where they have to determine the capabilities of electronic systems outside of their control. Conclusion The AOA appreciates the agency s efforts to align its various programs; however more steps need to be taken to streamline the requirements, such as the various data submission deadlines involving such programs as the Physician Quality Reporting System, value-based payment modifier, the EHR incentive program, and E-prescribing incentive program. These deadlines and other reporting requirements must be better aligned to eliminate the administrative burden and confusion caused by the current demands. The AOA also supports the agency s proposed exceptions to the application of the payment adjustment to EPs in CY 2015 and subsequent calendar years, including: 1) Exception to EPs who practice in areas without sufficient internet access; 2) Exception for new EPs for a limited time period after the EP has begun practicing; 3) Exception for extreme circumstances that make it impossible for an EP to demonstrate meaningful use requirements through no fault of their own during the reporting period. CMS also proposes exceptions for lack of face to face or telemedicine interaction with patients; lack of follow up with patients; lack of control over the availability of Certified E HR Technology at their practice locations. CMS says it does not believe that any one of these barriers taken independently constitutes an insurmountable hardship; however taken together they may pose a substantial obstacle. We disagree and believe physicians who fall into one or more of these three categories should be allowed an exception. Thank you for the opportunity to provide comments. We look forward to working with CMS on this and other issues of importance to the osteopathic community. Sincerely, Martin S. Levine, DO President

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